04-5195. Agency Information Collection Activities; Proposed Collection; Comment Request; Specific Requirements on Content and Format of Labeling for Human Prescription Drugs; Addition of “Geriatric Use” Subsection in the Labeling

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the “Geriatric Use” subsection in the labeling for human prescription drugs.

DATES:

Submit written or electronic comments on the collection of information by May 10, 2004.

ADDRESSES:

Submit electronic comments on the collection of information to: http://www.fda.gov/​dockets/​ecomments. Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20857. All comments should be identified with the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Karen L. Nelson, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION:

Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Specific Requirements on Content and Format of Labeling for Human Prescription Drugs; Addition of “Geriatric Use” Subsection in the Labeling (OMB Control Number 0910-0370)—Extension

Section 201.57(f)(10) (21 CFR 201.57(f)(10)) requires that the “Precautions” section of prescription drug labeling must include a subsection on the use of the drug in elderly or geriatric patients (aged 65 and over). The information collection burden imposed by this regulation is necessary to facilitate the safe and effective use of prescription drugs in older populations. The geriatric use subsection enables physicians to more effectively access geriatric information in physician prescription drug labeling.

Section 201.57(f)(10) requires that a specific geriatric indication, if any, that is supported by adequate and well-controlled studies in the geriatric population must be described under the “Indications and Usage” section of the labeling, and appropriate geriatric dosage must be stated under the “Dosage and Administration” section of the labeling. The “Geriatric use” subsection must cite any limitations on the geriatric indication, need for specific monitoring, specific hazards associated with the geriatric indication, and other information related to the safe and effective use of the drug in the geriatric population. The data summarized in this subsection of the labeling must be discussed in more detail, if appropriate, under “Clinical Pharmacology” or the “Clinical Studies” section. As appropriate, this information must also be contained in “Contraindications,” “Warnings,” and elsewhere in “Precautions.” Specific statements on geriatric use of the drug for an indication approved for adults generally, as distinguished from a specific geriatric indication, must be contained in the “Geriatric use” subsection and must reflect all information available to the sponsor that is relevant to the appropriate use of the drug in elderly patients. These statements are described further in § 201.57(f)(10).

Table 1.—Estimated Annual Reporting Burden¹

21 CFR Section	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Hours
201.57(f)(10)—new drug applications (NDAs)	73	1.48	108	8	864
201.57(f)(10)—abbreviated new drug applications (ANDAs)	96	4.67	449	2	898
Total					1,762
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: March 2, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.